70 Participants Needed

Abiraterone + Prednisone/Olaparib for Prostate Cancer

Recruiting at 17 trial locations
SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Northwestern University
Must be taking: LHRH analogues
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.

Who Is on the Research Team?

Maha H. Hussain, MD | Northwestern Medicine

Maha Hussain, MD, FACP, FASCO

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Men with metastatic castration-resistant prostate cancer and specific DNA repair defects (like ATM, BRCA mutations) can join. They must have a life expectancy of at least 6 months, be able to take oral meds, agree to use contraception for 3+ months after the trial, and not have had certain treatments like CYP17 inhibitors or chemotherapy for resistant disease. No major surgery or uncontrolled medical issues within 14 days before joining.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.
I agree to a biopsy to check for DNA repair defects in my cancer.
I agree to use contraception during and for 3 months after the study.
See 10 more

Exclusion Criteria

I have stopped taking all strong medications that affect liver enzymes.
I am allergic to medications similar to olaparib or abiraterone.
Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or of long QT syndrome.
See 28 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Abiraterone, Olaparib, or Abiraterone + Olaparib in 28-day cycles

Up to 2 years
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Abiraterone Acetate
  • Olaparib
  • Prednisone
Trial Overview The study is testing three approaches: Abiraterone/Prednisone alone, Olaparib alone, or both combined in men with advanced prostate cancer who have genetic changes affecting DNA repair. It's an open-label phase II trial where patients are randomly assigned to one of the treatment arms.
How Is the Trial Designed?
4Treatment groups
Active Control
Group I: Arm I: Abiraterone + PrednisoneActive Control2 Interventions
Group II: Arm II: OlaparibActive Control1 Intervention
Group III: Arm III: Abiraterone + Prednisone + OlaparibActive Control3 Interventions
Group IV: OlaparibActive Control1 Intervention

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Zytiga for:
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Approved in European Union as Zytiga for:
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Approved in Canada as Zytiga for:
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Approved in Japan as Zytiga for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Unbiased ResultsWe believe in providing patients with all the options.
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